Advair® DISKUS® Versus Serevent® DISKUS® For Chronic Obstructive Pulmonary Disease Exacerbations
A Randomized, Double-Blind, Parallel Group, 52-Week Study to Compare the Effect of Fluticasone Propionate/Salmeterol Diskus Combination Product 250/50mcg BID With Salmeterol Diskus 50mcg BID on the Annual Rate of Moderate/Severe Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease
1 other identifier
interventional
797
2 countries
110
Brief Summary
This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease) exacerbations. This study will last up to 56 weeks, and subjects will visit the clinic 10 times. Subjects will be given breathing tests and will record their breathing symptoms daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The two drugs used in this study have been approved by FDA for use in patients with COPD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2004
Typical duration for phase_4
110 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 22, 2005
CompletedFirst Posted
Study publicly available on registry
June 23, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedJanuary 20, 2017
January 1, 2017
2.5 years
June 22, 2005
January 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of moderate/severe exacerbations over a 52 week treatment period
Secondary Outcomes (1)
The time until the first moderate/severe exacerbation; the annual rate of exacerbations requiring oral corticosteroid treatment, and breathing tests conducted over one year
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of COPD.
- Current or previous cigarette smokers with a smoking history of at least 10 pack-years.
- History of at least 1 COPD exacerbation in the 12 months prior to screening.
- Forced expiratory volume in one second (FEV1) of less than or equal to 50% of predicted normal.
You may not qualify if:
- Diagnosis of asthma.
- Additional respiratory disorders other than COPD (eg, sarcoidosis, alpha-1 antitrypsin deficiency, cystic fibrosis, or active tuberculosis).
- Concurrent use of long-acting beta-agonists, long-acting anticholinergics, inhaled and oral corticosteroids, theophylline, investigational medications, ritonavir, and anti-leukotrienes.
- Lung resection surgery within 1 year of screening.
- Abnormal and clinically significant ECG findings at screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (110)
GSK Investigational Site
Jasper, Alabama, 35501, United States
GSK Investigational Site
Mobile, Alabama, 36608, United States
GSK Investigational Site
Glendale, Arizona, 85306, United States
GSK Investigational Site
Phoenix, Arizona, 85013, United States
GSK Investigational Site
Berkeley, California, 94705, United States
GSK Investigational Site
Fullerton, California, 92835, United States
GSK Investigational Site
Riverside, California, 92506, United States
GSK Investigational Site
Sacramento, California, 95825, United States
GSK Investigational Site
San Diego, California, 92123, United States
GSK Investigational Site
Vista, California, 92084, United States
GSK Investigational Site
Fort Collins, Colorado, 80528, United States
GSK Investigational Site
Stamford, Connecticut, 06902, United States
GSK Investigational Site
Atlantis, Florida, 33462, United States
GSK Investigational Site
Clearwater, Florida, 33756, United States
GSK Investigational Site
DeLand, Florida, 32720, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33316, United States
GSK Investigational Site
Pensacola, Florida, 32504, United States
GSK Investigational Site
Sarasota, Florida, 34239, United States
GSK Investigational Site
Tamarac, Florida, 33321, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Woodstock, Georgia, 30189, United States
GSK Investigational Site
Springfield, Illinois, 62702, United States
GSK Investigational Site
Elkhart, Indiana, 46154, United States
GSK Investigational Site
Evansville, Indiana, 47710, United States
GSK Investigational Site
Evansville, Indiana, 47714, United States
GSK Investigational Site
Indianapolis, Indiana, 46208, United States
GSK Investigational Site
South Bend, Indiana, 46617, United States
GSK Investigational Site
Iowa City, Iowa, 52242, United States
GSK Investigational Site
Olathe, Kansas, 66061, United States
GSK Investigational Site
Madisonville, Kentucky, 42431, United States
GSK Investigational Site
Lafayette, Louisiana, 70503, United States
GSK Investigational Site
New Orleans, Louisiana, 70112, United States
GSK Investigational Site
Shreveport, Louisiana, 71103, United States
GSK Investigational Site
Sunset, Louisiana, 70584, United States
GSK Investigational Site
Auburn, Maine, 04210, United States
GSK Investigational Site
Baltimore, Maryland, 21201, United States
GSK Investigational Site
Boston, Massachusetts, 02135, United States
GSK Investigational Site
Saint Joseph, Michigan, 49085, United States
GSK Investigational Site
Minneapolis, Minnesota, 55407, United States
GSK Investigational Site
Chesterfield, Missouri, 63017, United States
GSK Investigational Site
Jefferson City, Missouri, 65101, United States
GSK Investigational Site
Saint Charles, Missouri, 63301, United States
GSK Investigational Site
St Louis, Missouri, 63110, United States
GSK Investigational Site
Billings, Montana, 59102, United States
GSK Investigational Site
Butte, Montana, 59701, United States
GSK Investigational Site
Omaha, Nebraska, 68124, United States
GSK Investigational Site
Omaha, Nebraska, 68131, United States
GSK Investigational Site
Absecon, New Jersey, 08201, United States
GSK Investigational Site
Albany, New York, 12205, United States
GSK Investigational Site
Bay Shore, New York, 11706, United States
GSK Investigational Site
Ithaca, New York, 14850, United States
GSK Investigational Site
Larchmont, New York, 10538, United States
GSK Investigational Site
New York, New York, 10016, United States
GSK Investigational Site
Chapel Hill, North Carolina, 27599, United States
GSK Investigational Site
Charlotte, North Carolina, 28207, United States
GSK Investigational Site
Elizabeth City, North Carolina, 27909, United States
GSK Investigational Site
High Point, North Carolina, 27262, United States
GSK Investigational Site
Raleigh, North Carolina, 27612, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27157, United States
GSK Investigational Site
Canton, Ohio, 44718, United States
GSK Investigational Site
Chardon, Ohio, 44024, United States
GSK Investigational Site
Mogadore, Ohio, 44260, United States
GSK Investigational Site
Lake Oswego, Oregon, 97035, United States
GSK Investigational Site
Erie, Pennsylvania, 16508, United States
GSK Investigational Site
Hershey, Pennsylvania, 17033, United States
GSK Investigational Site
McKeesport, Pennsylvania, 15132, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15025, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15243, United States
GSK Investigational Site
East Providence, Rhode Island, 02914, United States
GSK Investigational Site
Providence, Rhode Island, 2909, United States
GSK Investigational Site
Gaffney, South Carolina, 29340, United States
GSK Investigational Site
Greer, South Carolina, 29651, United States
GSK Investigational Site
Simpsonville, South Carolina, 29681, United States
GSK Investigational Site
Spartanburg, South Carolina, 29303, United States
GSK Investigational Site
Bristol, Tennessee, 37620, United States
GSK Investigational Site
Chattanooga, Tennessee, 37403, United States
GSK Investigational Site
Johnson City, Tennessee, 37601, United States
GSK Investigational Site
Kingsport, Tennessee, 37660, United States
GSK Investigational Site
Dallas, Texas, 75390-9016, United States
GSK Investigational Site
Houston, Texas, 77074, United States
GSK Investigational Site
New Braunfels, Texas, 78130, United States
GSK Investigational Site
San Antonio, Texas, 78217, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
San Marcos, Texas, 78666, United States
GSK Investigational Site
Abingdon, Virginia, 24210, United States
GSK Investigational Site
Lynchburg, Virginia, 24501, United States
GSK Investigational Site
Newport News, Virginia, 23606, United States
GSK Investigational Site
Richmond, Virginia, 23225, United States
GSK Investigational Site
Bellingham, Washington, 98226, United States
GSK Investigational Site
Gig Harbor, Washington, 98335, United States
GSK Investigational Site
Kirkland, Washington, 98034, United States
GSK Investigational Site
Spokane, Washington, 99204, United States
GSK Investigational Site
Morgantown, West Virginia, 26505, United States
GSK Investigational Site
La Crosse, Wisconsin, 54601, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53209, United States
GSK Investigational Site
Vancouver, British Columbia, V5Z 3J5, Canada
GSK Investigational Site
Winnipeg, Manitoba, R2K 3S8, Canada
GSK Investigational Site
Saint John, New Brunswick, E2M 3W5, Canada
GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, A0G 1G0, Canada
GSK Investigational Site
Holyrood, Newfoundland and Labrador, A0A 2R0, Canada
GSK Investigational Site
Grimsby, Ontario, L3M 1P3, Canada
GSK Investigational Site
London, Ontario, N6C 4Y7, Canada
GSK Investigational Site
Thunder Bay, Ontario, P7A 4V7, Canada
GSK Investigational Site
Bonaventure, Quebec, G0C 1E0, Canada
GSK Investigational Site
Chandler, Quebec, G0C 1K0, Canada
GSK Investigational Site
Charlesbourg, Quebec, G1G 4A2, Canada
GSK Investigational Site
Gatineau, Quebec, J8Y 6S8, Canada
GSK Investigational Site
Saint-Léonard, Quebec, H1S 3A9, Canada
GSK Investigational Site
Sherbrooke, Quebec, J1H 1Z1, Canada
GSK Investigational Site
Trois-Rivières, Quebec, G8T 7A1, Canada
Related Publications (1)
Disantostefano RL, Li H, Rubin DB, Stempel DA. Which patients with chronic obstructive pulmonary disease benefit from the addition of an inhaled corticosteroid to their bronchodilator? A cluster analysis. BMJ Open. 2013 Apr 22;3(4):e001838. doi: 10.1136/bmjopen-2012-001838. Print 2013.
PMID: 23613569DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2005
First Posted
June 23, 2005
Study Start
December 1, 2004
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
January 20, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.